OEM Inspection Lead 1576

SimoTech

  • Dublin
  • Permanent
  • Full-time
  • 1 month ago
About SimoTechSimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.Why SimoTechWhat is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients' life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.OEM Inspection Lead 1576SimoTech has a new opportunity for an experienced OEM Inspection Lead to serve as the Technology Lead on a Syringe Filling Equipment Automation Expansion Project for a biopharmaceutical client based in Co. Dublin.The successful candidate will have minimum of 5 years' experience in deploying, qualifying, and optimizing automated visual inspection (AVI) systems for prefilled syringes in a GMP-regulated, sterile fill-finish environment.They will be responsible for collaborating with OEM vendors on system configuration, managing defect review processes, and driving continuous improvement to ensure inspection system performance meets quality and regulatory requirements.Key Responsibilities
  • Provide technical leadership and oversight for OEM automation on behalf of the client ensuring system configuration, defect libraries, and performance criteria are aligned with site and regulatory requirements.
  • Collaborate closely with the OEM supplier, system integrator, and internal teams to define the scope and standards of automation deliverables, deliver critical project documentation and ensure regulatory compliance.
  • Develop and manage defect libraries for known cosmetic and functional defects in prefilled syringes (e.g., particles, scratches, fill volume issues, stopper position).
  • Collaborate with cross-functional teams to define and optimise inspection parameters, rejection thresholds, and false reject rates.
  • Ensure all required functions are implemented and validated.
  • Capture, formalise, and disseminate client requirements to guide project execution.
  • Review and approve design deliverables such as Functional Specifications, Design Specifications, drawings, etc.
  • Maintain high standard of configuration and coding.
  • Plan, execute, and oversee FAT and SAT protocols.
  • Work closely with process owners, OEM team, design team and all stakeholders in delivery of project.
  • Own OEM automation lifecycle: define requirements, align vendor solutions, and confirm operational readiness.
  • Manage control changes and uphold high documentation standards throughout all project phases.
  • Deliver critical project documentation and oversee transition to operations.
  • Work closely with commissioning and qualification teams to establish the facility.
  • Provide support during facility start-up to ensure a smooth transition to operations.
Qualifications
  • Bachelor's degree in Engineering, Computer Science, Life Sciences or similar.
  • Experience working Rockwell systems FT Batch, FT View, Control Logix & Plant Pax.
  • Experience working with Aveva InTouch experience.
  • Experience in vision system configuration (Cognex, Koerber Vision System), camera tuning, or algorithm adjustments.
  • Understanding of serialisation and traceability requirements.
  • Machine safety directive expertise and experience on safety PLC systems.
  • Proven experience with drug production, especially fillfinish operations would be an advantage.
  • Demonstrates proven leadership ability, excellent interpersonal and communication skills, and robust project experience.
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.
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